The PTN conducts Phase 1-4 trials and data-based studies across a broad range of conditions affecting pediatric patients.
ONGOING STUDIES
| Study Name | Status | Population | Condition | Study Type | ClinicalTrials.gov ID |
|---|---|---|---|---|---|
| Antibiotic safety (SCAMP) | Enrolling | Premature infants | Intra-abdominal infections | Interventional | NCT01994993 |
| Anti-epileptic obesity | Enrolling | Obese children | Epilepsy | Interventional | NCT02993861 |
| Baby TAPE | Analysis ongoing | Newborns and young infants | NA (Weight estimation tool) | Interventional | |
| Baby TAPE III | Enrolling | Newborns and young infants | NA (Weight estimation tool) | Interventional | |
| Caffeine | Analysis ongoing | Premature infants and infants | Bronchopulmonary dysplasia | Retrospective data collection | |
| Commonly used drugs during lactation and infant exposure (CUDDLE) | Enrolling | Breastfeeding mothers and infants | Various (drugs administered regularly by physicians) | Interventional | NCT03511118 |
| Furosemide | Enrolling | Premature infants | Bronchopulmonary dysplasia | Interventional | NCT02527798 |
| Long-term Antipsychotic Pediatric Safety Trial (LAPS) | Enrolling | Children | Mono-antipsychotic therapies | Observational | NCT03522168 |
| Midazolam | Analysis ongoing | Children (≥2 y) | Seizures | Retrospective data analysis | NA |
| Personal protective equipment (PPE) | Enrollment closed | Research doctors and nurses | Evaluating impact of various PPE | Interventional | NA |
| POPS | Enrolling | Children (<21 y) | Various (drugs administered regularly by physicians) | Observational | NCT01431326 |
| Sildenafil II | Enrolling | Premature infants | Bronchopulmonary dysplasia | Phase 2 | NCT03142568 |
| Timolol | Enrolling | Infants | Infantile hemangioma | Phase 2 | NCT02913612 |
| Trimethoprim-sulfamethoxazole and clindamycin | Analysis ongoing | Children | Skin and soft tissue infections | Data from 3 protocols | NCT01431326, NCT01728363, NCT01744730 |
COMPLETED STUDIES
| Study Name | Status | Population | Condition | Study Type | ClinicalTrials.gov ID |
|---|---|---|---|---|---|
| Acyclovir | Completed; label changed | Premature infants | Systemic infection | Phase 1 | NCT00942084 |
| Acyclovir retrospective | Closed; clinical study report submitted to FDA | Infants | Herpes simplex virus | Retrospective data collection | |
| Ampicillin | Published; clinical study report submitted to FDA | Infants | Bacterial infections including sepsis and meningitis | Secondary data analysis | |
| Anti-staph trio | Completed | Premature infants | Staphylococcal infections | Interventional | NCT01728363 |
| Clindamycin obesity | Clinical study report submitted to FDA | Obese children | Staphylococcal infections | Phase 1 | NCT01744730 |
| Diuretic safety | Clinical study report submitted to FDA | Infants | Bronchopulmonary dysplasia | Retrospective observational | NA |
| Fluconazole safety | Published; clinical study report submitted to FDA | Infants | Candidemia | Meta-analysis | NCT00734539 |
| Hydroxyurea | Clinical study report submitted to FDA | Children (2-4 y) | Sickle cell anemia or sickle beta-zero thalassemia | Phase 2 | NCT01506544 |
| Lisinopril PK | Completed; label changed | Children and adolescents (2-17 y) | Kidney transplant; high blood pressure | Interventional | NCT01491919 |
| Lorazepam | Completed; label changed | Children and adolescents (3 mo-18 y) | Status epilepticus (Status 1) | Interventional | NCT00114569 |
| Lorazepam or diazepam | Clinical study report submitted to FDA | Children and adolescents (3 mo-18 y) | Pediatric status epilepticus (Status 2) | Interventional | NCT00621478 |
| Meropenem | Completed; label changed | Infants | Intra-abdominal infections | Interventional | NCT00621192 |
| Methadone | Completed | Children | Opiate withdrawal | Observational | NCT01945736 |
| Metronidazole | Published; clinical study report submitted to FDA | Premature infants | Serious infection caused by anaerobic bacteria | Interventional | NCT01222585 |
| Obesity informatics | Published | Children | Various | Systematic literature review | NA |
| Pantoprazole | Completed | Obese children | GERD | Phase 1 | NCT02186652 |
| Pediatrix meta-analysis | Published; clinical study report submitted to FDA | Infants | Various | Meta-analysis | NA |
| Sildenafil | Completed | Premature infants | Bronchopulmonary dysplasia | Phase 1 | NCT01670136 |
| TAPE | Published; clinical study report submitted to FDA | Children (2-16 y) | NA (Mercy Method™ for weight estimation) | Observational | NCT01507090 |
